Is the Multi-Attribute Method (MAM) the Next Big Thing? A High-Resolution Accurate Mass Multi-Attribute Method for Critical Quality Attribute Monitoring

the focus has turned to automation and software development to allow for automated identification and quantitative analysis of each molecular attribute. With automation and software developments, a true benefit of MAM can be realized by building a comprehensive molecular attribute database linked to process conditions which can then be used to increase product and process knowledge throughout the development pipeline. With this increased product and process knowledge, MAM can reduce the amount of time taken to develop a product, reduce the time needed to manufacture and release a product by add-ing efficient process controls, and reduce the time needed to investigate a process issue. MAM can help to solve major manufacturing challenges plaguing the biopharmaceutical industry today as they strive to develop more biotherapeutics on a faster timeline. The multi-attribute for the of monoclonal critical quality describe the optimization and applica-tion of the Multi- Attribute Method as a complete workflow to monitor CQAs of the NISTmAb including glycosylation, deamidation, isomerization, succinimide formation, oxidation,